Recall Z-0027-2016
Zimmer, Inc. · initiated August 11, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Codes / lots: Item No. 00-4836-080-00; Lot 56555128
Reason for recall
It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat
FDA-determined cause: Process control
Action taken
On 8/11/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 a.m. and 5:00 p.m. EST.
Details
- Recall number
- Z-0027-2016
- Initiated
- August 11, 2015
- Posted by FDA
- October 6, 2015
- Terminated
- March 15, 2016
- Product code
- FSM – Tray, Surgical, Instrument
- Quantity
- 18 units
- Distribution
- Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
- Recalling firm
- Zimmer, Inc., Warsaw, IN